AVEIR Remote Care System Non-Significant Risk Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-10

Study Completion Date

2024-08-30

Brief Summary

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The goal of the study is to understand the performance of the AVEIR Remote Care System in an initial patient cohort which will inform the ability to offer a remote follow-up solution to all patients implanted with Aveir LP devices.

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Detailed Description

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To collect acute performance data about the AVEIR Remote Care System in participants implanted with a compatible dual or single chamber Aveir Leadless Pacemaker System by participants completing remote transmissions with the system

Conditions

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Cardiac Pacemaker Cardiac Rhythm Disorder Bradycardia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational, Single Arm, Non Randomized

Aveir leadless pacemaker system patients

AVEIR remote care system

Intervention Type DEVICE

In-clinic or an at-home system designed to support remote follow up in Aveir leadless pacemaker patients

Interventions

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AVEIR remote care system

In-clinic or an at-home system designed to support remote follow up in Aveir leadless pacemaker patients

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject must provide written informed consent prior to any study-related procedure.
* Subject is willing and has consented to study clinical procedure.
* Subject is ≥ 18 years of age or age of legal consent, whichever age is greater
* Subject has an active, appropriately functioning Aveir leadless pacemaker system
* Subject is willing to use the device

Exclusion Criteria

* Subject is unable to read/write at a sufficient level to provide informed consent.
* Subject is unable to make the decision to participate in a clinical investigation on their own or are unable to fully understand all aspects of the investigation that are relevant to the decision to participate.
* Subject has presence of medical, social, or psychological conditions that, in the investigator's opinion, could confound the study, limit the subject's ability to participate in the clinical investigation .

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes